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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

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MPRI SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number 694958
Device Problem Decreased Sensitivity
Event Date 01/07/2020
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the right ventricular (rv) lead has diminished sensing. A follow up with the patient's healthcare provider yielded that the lead continues to be monitored with no intervention performed. The lead remains in use. No patient complications have been reported as a result of this event.

 
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Brand NameSPRINT FIDELIS
Type of DeviceDEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer (Section G)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view , MN 55112
7635055378
MDR Report Key9656094
Report Number2649622-2020-02544
Device Sequence Number1
Product CodeLWS
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 01/31/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/31/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/18/2007
Device MODEL Number694958
Device Catalogue Number694958
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/25/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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